Cleared Traditional

K942774 - POLYSKIN(R) M.R. MOIST RESPONSIVE TRANSPARENT DRESSING (FDA 510(k) Clearance)

K942774 · The Kendal Co. · General & Plastic Surgery device
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Jul 1994
Decision
37d
Days
-
Risk

K942774 is an FDA 510(k) clearance for the POLYSKIN(R) M.R. MOIST RESPONSIVE TRANSPARENT DRESSING. Classified as Dressing, Wound And Burn, Occlusive (product code MGP).

Submitted by The Kendal Co. (Franklin, US). The FDA issued a Cleared decision on July 20, 1994 after a review of 37 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all The Kendal Co. devices

Submission Details

510(k) Number K942774 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received June 13, 1994
Decision Date July 20, 1994
Days to Decision 37 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 114d · This submission: 37d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MGP Dressing, Wound And Burn, Occlusive
Device Class -